Remodeling of Abdominal Aortic Angulation and Curvature After Endovascular Aneurysm Repair in Patients With vs Without Late Type Ia Endoleak or Endograft Migration.

PURPOSE: To investigate aortic remodeling of the supra- and infrarenal aorta from preoperative to 1 month and midterm follow-up after endovascular aneurysm repair (EVAR) by analyzing changes in angulation and curvature in patients with vs without late type Ia endoleak or device migration. MATERIALS AND METHODS: From a multicenter database, 35 patients (mean age 76±5 years; 31 men) were identified with late (>1 year) type Ia endoleak or endograft migration (≥10 mm) and defined as the complication group. The control group consisted of 53 patients (mean age 75±7 years; 48 men) with >1-year computed tomography angiography (CTA) follow-up and no evidence of endoleaks. Suprarenal and infrarenal angles were measured on centerline reconstructions of the preoperative, 1-month, and midterm CTA scans. The value and location relative to baseline of maximum suprarenal and infrarenal curvature were determined semiautomatically using dedicated software. Changes were determined at 1 month compared with the preoperative CTA and at midterm compared with 1 month. RESULTS: Preoperative suprarenal angulation was significantly greater in the complication group compared to the controls (34°±18° vs 24°±17°, p=0.008). It decreased significantly at 1 month in the complication group (29°±16°, p=0.011) and at midterm follow-up in the controls (20°±19°, p<0.001). Preoperative infrarenal angulation was not significantly different (57°±15° vs 49°±24°, p=0.114). This measurement increased significantly through midterm follow-up in the complication group (63°±23°, p<0.001) but remained stable in the controls (46°±22°). Preoperative suprarenal curvature was not significantly different (38±22 m-1 vs 29±25 m-1, p=0.115). This variable increased significantly through midterm follow-up in the complication group (44±22 m-1) but remained constant in the controls (28±22 m-1). Preoperative infrarenal curvature was significantly greater in the complication group (77±29 m-1 vs 65±28 m-1, p=0.047) and decreased significantly in both groups during midterm follow-up (50±17 m-1 vs 41±19 m-1 p=0.033). The location of the maximum curvature with regard to baseline shifted significantly distally in the complication group (54±43 to 72±41 mm, p<0.001), while it remained stable in the controls (46±33 to 48±31 mm). CONCLUSION: At midterm follow-up, significant differences in supra- and infrarenal angulation and curvature were observed between patients with vs without type Ia endoleak or migration. The location of the maximum curvature shifted distally in patients with complications. The aortic morphology is more stable during midterm follow-up in the patients without endoleaks.

First-in-Human Study of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure-Related Bleeding Events.

OBJECTIVES: To evaluate the safety and accuracy of the Early Bird Bleed Monitoring System (EBBMS; Saranas) for the detection of access-site related bleeds in humans undergoing endovascular procedures. BACKGROUND: Bleeding complications after endovascular procedures are frequent and associated with poor prognosis. The EBBMS is a novel technology designed to detect in real time the onset, progression, and severity of internal bleeds. METHODS: The EBBMS was used during and after endovascular procedures, either as a venous or arterial access sheath. The primary endpoint was the level of agreement in bleed detection between the Saranas EBBMS and postprocedural computed tomography. RESULTS: From August 2018 to December 2018, a total of 60 patients from five United States sites were enrolled and underwent elective endovascular procedures (transcatheter aortic valve replacement [67%], percutaneous coronary intervention [13%], percutaneous ventricular assist device [8%], balloon aortic valvuloplasty [7%], transcatheter mitral valve repair/replacement [4%], and endovascular aneurysmal repair [2%]). The EBBMS detected the absence of bleeds in 21 patients (35%) and bleeds in 39 patients (65%), with bleeding severity level 1 in 20 patients (33%), level 2 in 15 patients (25%), and level 3 in 4 patients (7%). Bleeding detection occurred during the procedure in 31% of patients and post procedure in 69% of patients. The level of agreement between the EBBMS and computed tomography scan was high (Cohen's kappa=0.84). No device-related complications were reported. CONCLUSIONS: The EBBMS was safe across a variety of endovascular procedures and detected bleeding events with a high level of agreement with postprocedural computed tomography scan.

Determination of Endograft Apposition, Position, and Expansion in the Aortic Neck Predicts Type Ia Endoleak and Migration After Endovascular Aneurysm Repair.

PURPOSE: To describe the added value of determining changes in position and apposition on computed tomography angiography (CTA) after endovascular aneurysm repair (EVAR) to detect early caudal displacement of the device and to prevent type Ia endoleak. METHODS: Four groups of elective EVAR patients were selected from a dataset purposely enriched with type Ia endoleak and migration (>10 mm) cases. The groups included cases of late type Ia endoleak (n=36), migration (n=9), a type II endoleak (n=16), and controls without post-EVAR complications (n=37). Apposition of the endograft fabric with the aortic neck, shortest distance between the fabric and the renal arteries, expansion of the main body (or dilatation of the aorta in the infrarenal sealing zone), and tilt of the endograft toward the aortic axis were determined on the first postoperative and the last available CTA scan without type Ia endoleak or migration. Differences in these endograft dimensions were compared between the first vs last scan and among the 4 groups. RESULTS: No significant differences in endograft configurations were observed among the groups on the first postoperative CTA scan. On the last CTA scan before a complication arose, the position of the fabric relative to the renal arteries, expansion of the main body, and apposition of the fabric with the aortic neck were significantly different between the type Ia endoleak (median follow-up 15 months) and migration groups (median follow-up 23 months) compared with the control group (median follow-up 19 months). Most endograft dimensions had changed significantly compared with the first postoperative CTA scan for all groups. Apposition had increased in the control group but had decreased significantly in the type Ia endoleak and migration groups. CONCLUSION: Progressive changes in dimensions of the endograft within the infrarenal neck could be detected on regular CTA scans before the complication became urgent in many patients.

Matched cohort comparison of endovascular abdominal aortic aneurysm repair with and without EndoAnchors.

OBJECTIVE: The objective of this study was to examine whether prophylactic use of EndoAnchors (Medtronic, Santa Rosa, Calif) contributes to improved outcomes after endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms through 2 years. METHODS: The Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) subjects who received prophylactic EndoAnchors during EVAR were considered for this analysis. Imaging data of retrospective subjects who underwent EVAR at ANCHOR enrolling institutions were obtained to create a control sample. Nineteen baseline anatomic measurements were used to perform propensity score matching, yielding 99 matched pairs. Follow-up imaging of the ANCHOR and control cohorts was then compared to examine outcomes through 2 years, using Kaplan-Meier survival analysis. RESULTS: Freedom from type Ia endoleak was 97.0% ± 2.1% in the ANCHOR cohort and 94.1% ± 2.5% in the control cohort through 2 years (P = .34). The 2-year freedom from neck dilation in the ANCHOR and control cohorts was 90.4% ± 5.6% and 87.3% ± 4.3%, respectively (P = .46); 2-year freedom from sac enlargement was 97.0% ± 2.1% and 94.0% ± 3.0%, respectively (P = .67). No device migration was observed. Aneurysm sac regression was observed in 81.1% ± 9.5% of ANCHOR subjects through 2 years compared with 48.7% ± 5.9% of control subjects (P = .01). Cox regression analysis found an inverse correlation between number of hostile neck criteria met and later sac regression (P = .05). Preoperative neck thrombus circumference and infrarenal diameter were also variables associated with later sac regression, although not to a significant degree (P = .10 and P = .06, respectively). Control subjects with thrombus were significantly less likely to experience later sac regression than those without thrombus (6% and 43%, respectively; P = .001). In ANCHOR subjects, rate of regression was not significantly different in subjects with or without thrombus (33% and 36%, respectively; P = .82). Control subjects with wide aortic necks (>28 mm) were observed to experience sac regression at a lower rate than subjects with smaller diameter necks (10% and 44%, respectively; P = .004). Wide neck and normal neck subjects implanted with EndoAnchors experienced later sac regression at roughly equivalent rates (44% and 33%, respectively; P = .50). CONCLUSIONS: In propensity-matched cohorts of subjects undergoing EVAR, the rate of sac regression in subjects treated with EndoAnchors was significantly higher. EndoAnchors may mitigate the adverse effect of wide infrarenal necks and neck thrombus on sac regression, although further studies are needed to evaluate the long-term effect of EndoAnchors.

A Semiautomated Method for Measuring the 3-Dimensional Fabric to Renal Artery Distances to Determine Endograft Position After Endovascular Aneurysm Repair.

PURPOSE: To report a methodology for 3-dimensional (3D) assessment of the stent-graft deployment accuracy after endovascular aneurysm repair (EVAR). METHODS: A methodology was developed and validated to calculate the 3D distances between the endograft fabric and the renal arteries over the curve of the aorta. The shortest distance between one of the renal arteries and the fabric (SFD) and the distance from the contralateral renal artery to the fabric (CFD) were determined on the first postoperative computed tomography (CT) scan of 81 elective EVAR patients. The SFDs were subdivided into a target position (0-3 mm distal to the renal artery), high position (partially covering the renal artery), and low position (>3 mm distal to the renal artery). Data are reported as the median (interquartile range, IQR). RESULTS: Intra- and interobserver agreements for automatic and manual calculation of the SFD and CFD were excellent (ICC >0.892, p<0.001). The median SFD was 1.4 mm (IQR -0.9, 3.0) and the median CFD was 8.0 mm (IQR 3.9, 14.2). The target position was achieved in 44%, high position in 30%, and low position in 26% of the patients. The median slope of the endograft toward the higher renal artery was 2.5° (IQR -5.5°, 13.9°). CONCLUSION: The novel methodology using 3D CT reconstructions enables accurate evaluation of endograft position and slope within the proximal aortic neck. In this series, only 44% of endografts were placed within the target position with regard to the lowermost renal artery.

Predictors of early aortic neck dilatation after endovascular aneurysm repair with EndoAnchors.

OBJECTIVE: Dilatation of the aorta within the proximal neck after endovascular aneurysm repair (EVAR) can be associated with late endoleaks and migration. This study was designed to identify predictors of early neck dilation in patients undergoing EVAR with Heli-FX EndoAnchors (Medtronic, Santa Rosa, Calif) measured perioperatively to 1 year at different longitudinal levels of neck length. METHODS: The study group of Aneurysm Treatment Using the Heli-FX Aortic Securement System (ANCHOR) comprises 257 consecutive patients prospectively enrolled between April 2012 and September 2014 undergoing EVAR with Heli-FX EndoAnchor implantation at 38 investigational sites. Only patients undergoing EndoAnchor implantation at the time of the initial EVAR were included (primary treatment arm). Aortic diameter was measured at the suprarenal level and at three levels within the proximal neck. Neck dilatation was assessed in 209 patients with adequate computed tomography imaging at baseline and 1 month and in 62 patients at 1 month and 1 year (mean, 11.9 ± 4.0 months). Multivariable analyses were performed to identify independent predictors of perioperative (baseline to 1 month) and early postoperative (1 month to 1 year) aortic dilation at each level; analyses included 6 candidate variables, 6 clinical, and 14 anatomic run in eight models (one at each of the four aortic levels for both time frames). RESULTS: The mean aortic neck dilation at 1 month was 0.2 ± 1.7 mm, 0.7 ± 2.2 mm, and 0.9 ± 3.6 mm at 0 mm, 5 mm, and 10 mm below the lowest renal artery, and 0.0 ± 1.5 mm at the suprarenal level. From 1 month to 1 year, neck dilatation was 0.5 ± 1.6 mm, 0.4 ± 1.5 mm, 0.2 ± 1.8 mm, and -0.3 ± 1.1 mm at the same four levels, respectively. Dilatation of ≥3 mm at level 5 mm distal to the lowest renal artery was observed in 26 patients (12.5%) from preoperative to 1 month and in 5 patients (8.1%) between 1 month and 1 year. Multivariable regression identified several variables predictive of perioperative (preoperative to 1 month) neck dilatation: baseline neck diameter, mural calcium (protective), and endografts with a suprarenal stent. Neck dilatation between 1 month and 1 year was associated with baseline neck diameter, neck length (protective), neck angulation, device oversizing, number of EndoAnchors implanted (protective), and endografts with a suprarenal stent. CONCLUSIONS: Aortic diameter and graft oversizing appear to be independent risk factors for early aortic neck dilatation. EndoAnchors have a protective effect on neck dilatation at their usual level of deployment.

Aortic Curvature Is a Predictor of Late Type Ia Endoleak and Migration After Endovascular Aneurysm Repair.

PURPOSE: To evaluate the association between aortic curvature and other preoperative anatomical characteristics and late (>1 year) type Ia endoleak and endograft migration in endovascular aneurysm repair (EVAR) patients. METHODS: Eight high-volume EVAR centers contributed 116 EVAR patients (mean age 81±7 years; 103 men) to the study: 36 patients (mean age 82±7 years; 31 men) with endograft migration and/or type Ia endoleak diagnosed >1 year after the initial EVAR and 80 controls without early or late complications. Aortic curvature was calculated from the preoperative computed tomography scan as the maximum and average curvature over 5 predefined aortic segments: the entire infrarenal aortic neck, aneurysm sac, and the suprarenal, juxtarenal, and infrarenal aorta. Other morphological characteristics included neck length, neck diameter, mural neck calcification and thrombus, suprarenal and infrarenal angulation, and largest aneurysm sac diameter. Independent risk factors were identified using backward stepwise logistic regression. Relevant cutoff values for each of the variables in the final regression model were determined with the receiver operator characteristic curve. RESULTS: Logistic regression identified maximum curvature over the length of the aneurysm sac (>47 m-1; p=0.023), largest aneurysm sac diameter (>56 mm; p=0.028), and mural neck thrombus (>11° circumference; p<0.001) as independent predictors of late migration and type Ia endoleak. CONCLUSION: Aortic curvature is a predictor for late type Ia endoleak and endograft migration after EVAR. These findings suggest that aortic curvature is a better parameter than angulation to predict post-EVAR failure and should be included as a hostile neck parameter.

Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter.

PURPOSE: To report the final 2-year data on the efficacy and safety of a nitinol retrievable inferior vena cava (IVC) filter for protection against pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective multicenter trial of 200 patients with temporary indications for caval filtration who underwent implantation of the Denali IVC filter. After filter placement, all patients were followed for 2 years after placement or 30 days after filter retrieval. The primary endpoints were technical success of filter implantation in the intended location and clinical success of filter placement and retrieval. Secondary endpoints were incidence of clinically symptomatic recurrent PE, new or propagating deep vein thrombosis (DVT), and filter-related complications including migration, fracture, penetration, and tilt. RESULTS: Filter placement was technically successful in 199 patients (99.5%). Filters were clinically successful in 190 patients (95%). The rate of PE was 3% (n = 6), with 5 patients having a small subsegmental PE and 1 having a lobar PE. New or worsening DVT was noted in 26 patients (13%). Filter retrieval was attempted 125 times in 124 patients and was technically successful in 121 patients (97.6%). The mean filter dwell time at retrieval was 200.8 days (range, 5-736 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of filter retrieval or during follow-up. CONCLUSIONS: The Denali IVC filter exhibited high success rates for filter placement and retrieval while maintaining a low complication rate in this clinical trial.

Aortic curvature as a predictor of intraoperative type Ia endoleak.

OBJECTIVE: Hostile infrarenal neck characteristics are associated with complications such as type Ia endoleak after endovascular aneurysm repair. Aortic neck angulation has been identified as one such characteristic, but its association with complications has not been uniform between studies. Neck angulation assumes triangular oversimplification of the aortic trajectory, which may explain conflicting findings. By contrast, aortic curvature is a measurement that includes the bending rate and tortuosity and may provide better predictive value for neck complications. METHODS: Data were retrieved from the Heli-FX (Aptus Endosystems, Inc, Sunnyvale, Calif) Aortic Securement System Global Registry (ANCHOR). One cohort included patients who presented with intraoperative endoleak type Ia at the completion angiogram as the indication for EndoAnchors (Aptus Endosystems), and a second cohort comprised those without intraoperative or late type Ia endoleak (controls). The aortic trajectory was divided into six segments with potentially different influence on the stent graft performance: suprarenal, juxtarenal, and infrarenal aortic neck (-30 to -10 mm, -10 to 10 mm, and 10-30 mm from the lowest renal artery, respectively), the entire aortic neck, aneurysm sac, and terminal aorta (20 mm above the bifurcation to the bifurcation). Maximum and average curvature were automatically calculated over the six segments by proprietary custom software. Aortic curvature was compared with other standard neck characteristics, including neck length, neck diameter, maximum aneurysm sac diameter, neck thrombus and calcium thickness and circumference, suprarenal angulation, infrarenal angulation, and the neck tortuosity index. Independent risk factors for intraoperative type Ia endoleak were identified using backwards stepwise logistic regression. For the variables in the final regression model, suitable cutoff values in relation to the prediction of acute type Ia endoleak were defined with the area under the receiver operating characteristic curve. RESULTS: The analysis included 64 patients with intraoperative type Ia endoleak and 79 controls. Logistic regression identified only aortic neck calcification and aortic curvature, expressed over the juxtarenal aortic neck, the aneurysm sac, and the terminal aorta, as independent predictors of intraoperative type Ia endoleak. CONCLUSIONS: Together with aortic neck calcification, aortic curvature appears to be the best predictor of intraoperative type Ia endoleak, as expressed within the juxtarenal aortic neck, the aneurysm sac, and the terminal aorta. Aortic neck angulation was not a predictor for acute failure. Aortic curvature may provide a better anatomic characteristic to define patients at risk for early complications after endovascular aneurysm repair.

Cost-effectiveness of endovascular repair, open repair, and conservative management of splenic artery aneurysms.

OBJECTIVE: Open repair (OPEN) and conservative management (CONS) have been the treatments of choice for splenic artery aneurysms (SAAs) for many years. Endovascular repair (EV) has been increasingly used with good short-term results. In this study, we evaluated the cost-effectiveness of OPEN, EV, and CONS for the treatment of SAAs. METHODS: A decision analysis model was developed using TreeAge Pro 2013 software (TreeAge Inc, Williamstown, Mass) to evaluate the cost-effectiveness of the different treatments for SAAs. A hypothetical cohort of 10,000 55-year-old female patients with SAAs was assessed in the reference-case analysis. Perioperative mortality, disease-specific mortality rates, complications, rupture risks, and reinterventions were retrieved from a recent and extensive meta-analysis. Costs were analyzed with the 2014 Medicare database. The willingness to pay was set to $60,000/quality-adjusted life years (QALYs). Outcomes evaluated were QALYs, costs from the health care perspective, and the incremental cost-effectiveness ratio (ICER). Extensive sensitivity analyses were performed and different clinical scenarios evaluated. Probabilistic sensitivity analysis was performed to include the uncertainty around the variables. A flowchart for clinical decision-making was developed. RESULTS: For a 55-year-old female patient with a SAA, EV has the highest QALYs (11.32; 95% credibility interval [CI], 9.52-13.17), followed by OPEN (10.48; 95% CI, 8.75-12.25) and CONS (10.39; 95% CI, 8.96-11.87). The difference in effect for 55-year-old female patients between EV and OPEN is 0.84 QALY (95% CI, 0.42-1.34), comparable with 10 months in perfect health. EV is more effective and less costly than OPEN and more effective and more expensive compared with CONS, with an ICER of $17,154/QALY. Moreover, OPEN, with an ICER of $223,166/QALY, is not cost-effective compared with CONS. In elderly individuals (age >78 years), the ICER of EV vs CONS is $60,503/QALY and increases further with age, making EV no longer cost-effective. Very elderly patients (age >93 years) have higher QALYs and lower costs when treated with CONS. The EV group has the highest number of expected reinterventions, followed by CONS and OPEN, and the number of expected reinterventions decreases with age. CONCLUSIONS: EV is the most cost-effective treatment for most patient groups with SAAs, independent of the sex and risk profile of the patient. EV is superior to OPEN, being both cost-saving and more effective in all age groups. Elderly patients should be considered for CONS, based on the high costs in relation to the very small gain in health when treated with EV. The very elderly should be treated with CONS.

Open repair, endovascular repair, and conservative management of true splenic artery aneurysms.

OBJECTIVE: True splenic artery aneurysms (SAAs) are a rare but potentially fatal pathology. For many years, open repair (OPEN) and conservative management (CONS) were the treatments of choice, but throughout the last decade endovascular repair (EV) has become increasingly used. The purpose of the present study was to perform a systematic review and meta-analysis evaluating the outcomes of the three major treatment modalities (OPEN, EV, and CONS) for the management of SAAs. METHODS: A systematic review of all studies describing the outcomes of SAAs treated with OPEN, EV, or CONS was performed using seven large medical databases. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed to ensure a high-quality review. All articles were subject to critical appraisal for relevance, validity, and availability of data regarding characteristics and outcomes. All data were systematically pooled, and meta-analyses were performed on several outcomes, including early and late mortality, complications, and number of reinterventions. RESULTS: Original data of 1321 patients with true SAAs were identified in 47 articles. OPEN contained 511 patients (38.7%) in 31 articles, followed by 425 patients (32.2%) in CONS in 16 articles and 385 patients (29.1%) in EV in 33 articles. The CONS group had fewer symptomatic patients (9.5% vs 28.7% in OPEN and 28.8% in EV; P < .001) and fewer ruptured aneurysms (0.2% vs 18.4% in OPEN and 8.8% in EV; P < .001), but no significant differences were found in existing comorbidities. CONS patients were usually older and had smaller-sized aneurysms than patients in the OPEN and EV groups. The only identified difference in baseline characteristics between OPEN and EV was the number of ruptured aneurysms (18.4% vs 8.8%; P < .001). OPEN had a higher 30-day mortality than EV (5.1% vs 0.6%; P < .001), whereas minor complications occurred in a larger number of the EV patients. EV required more reinterventions per year (3.2%) compared with OPEN (0.5%) and CONS (1.2%; P < .001). The late mortality rate was higher in patients treated with CONS (4.9% vs 2.1% in OPEN and 1.4% in EV; P = .04). CONCLUSIONS: EV of SAA has better short-term results compared with OPEN, including significantly lower perioperative mortality. OPEN is associated with fewer late complications and fewer reinterventions during follow-up. Patients treated with CONS showed a higher late mortality rate. Ruptured SAAs are predictors of a significantly higher perioperative mortality compared with nonruptured SAAs in the OPEN and EV groups.

Endovascular vs. open repair of complicated acute type B aortic dissections.

Purpose : To assess the comparative effectiveness of thoracic endovascular aortic repair (TEVAR) vs. open surgical repair (OSR) of complicated acute type B aortic dissections (cABAD) using decision analysis. Methods : A decision analysis comparing TEVAR and OSR for cABAD included variables extracted from the best-available evidence. Main outcomes were quality-adjusted life years (QALYs), presented with the 95% credibility intervals (CI), and number of reinterventions over the remaining lifetime. Different clinical scenarios, including age, gender, and risk profile were analyzed. Parameter uncertainty was analyzed using probabilistic sensitivity analysis. Results : In the reference case, a cohort of 55-year-old men, TEVAR was preferred over OSR: 7.07 QALYs (95% CI 6.77 to 7.38) vs. 6.34 QALYs (95% CI 6.04 to 6.66) for OSR. The difference of 0.73 QALYs (95% CI 0.29 to 1.17) is equal to 8.5 months in perfect health. TEVAR was more effective in all analyzed cases and age groups. Perioperative mortality was the most important variable affecting the difference between OSR and TEVAR, followed by the relative risk and percentage of aortic-related complications. Total expected reinterventions were 0.43/patient (TEVAR) and 0.35/patient (OSR). Conclusion : The results of this decision model for the treatment of cABAD suggest that TEVAR is preferred over OSR. Although a higher number of reinterventions is expected, the total effectiveness of TEVAR is higher for all age groups. OSR should be reserved for patients whose aortic anatomy is unsuitable for endovascular repair.

The DENALI Trial: an interim analysis of a prospective, multicenter study of the Denali retrievable inferior vena cava filter.

PURPOSE: To assess safety and effectiveness of a nitinol retrievable inferior vena cava (IVC) filter in patients who require caval interruption to protect against pulmonary embolism (PE). MATERIALS AND METHODS: Two hundred patients with temporary indications for an IVC filter were enrolled in this prospective, multicenter clinical study. Patients undergoing filter implantation were to be followed for 2 years or for 30 days after filter retrieval. At the time of the present interim report, all 200 patients had been enrolled in the study, and 160 had undergone a retrieval attempt or been followed to 6 months with their filter in place. Primary study endpoints included technical and clinical success of filter placement and retrieval. Patients were also evaluated for recurrent PE, new or worsening deep vein thrombosis, and filter migration, fracture, penetration, and tilt. RESULTS: Clinical success of placement was achieved in 94.5% of patients (172 of 182), with a one-sided lower limit of the 95% confidence interval of 90.1%. Technical success rate of filter placement was 99.5%. Technical success rate of retrieval was 97.3%; 108 filters were retrieved in 111 attempts. In two cases, the filter apex could not be engaged with a snare, and one device was engaged but could not be removed. Filter retrievals occurred at a mean indwell time of 165 days (range, 5-632 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of retrieval or 6-month follow-up. CONCLUSIONS: In this interim report, the nitinol retrievable IVC filter provided protection against pulmonary embolism, and the device could be retrieved with a low rate of complications.

A comparison of open and endovascular revascularization for chronic mesenteric ischemia in a clinical decision model.

OBJECTIVE: Open revascularization (OR) has been the treatment of choice for chronic mesenteric ischemia (CMI) for many years, but endovascular revascularization (EV) has been increasingly used with good short-term results. In this study, we evaluated the comparative effectiveness and cost-effectiveness of EV and OR in patients with CMI refractory to conservative management. METHODS: A Markov-state transition model was developed using TreeAge Pro 2012 (TreeAge Inc, Williamstown, Mass) to simulate a hypothetical cohort of 10,000 65-year-old female patients with CMI requiring treatment with either OR or EV. Data for the model, including perioperative and long-term overall mortality risks, disease-specific mortality risks, complications, and reintervention and patency rates, were retrieved from original studies and systematic reviews about CMI. Costs were analyzed with the 2013 Medicare database. Outcomes evaluated were quality-adjusted life-years (QALYs), costs from the health care perspective, and the incremental cost-effectiveness ratio. Extensive sensitivity analyses were performed and different clinical scenarios evaluated. Probabilistic sensitivity analysis was performed to assess robustness of the model. RESULTS: For a reference-case 65-year-old female patient with CMI and an average risk for operation, EV is preferred with 10.03 QALYs (95% credibility interval [CI], 9.76-10.29) vs 9.59 after OR (95% CI, 9.29-9.87). The difference is comparable to 5 months in perfect health: 0.44 QALY (95% CI, 0.13-0.76). For 65-year-old men, this was 8.71 QALYs (95% CI, 8.48-8.94) for EV vs 8.42 (95% CI, 8.14-8.63) for OR. Sensitivity analysis showed that for younger patients, EV results in a higher increase in QALYs compared with older patients. Total expected reinterventions per patient are 1.70 for EV vs 0.30 for OR. Total expected health care costs for the reference-case patient were $39,942 (95% CI, $28,509-$53,380) for OR and $38.217 (95% CI, $29,329-$48,309) for EV. For men, this was $39,375 (95% CI, $28,092-$52,853) for OR and $35,903 (95% CI, $27,685-$45,597) for EV. For patients younger than 60 years, EV is a more expensive treatment strategy compared with OR, but with an incremental cost-effectiveness ratio for EV of less than $60,000/QALY. For patients 60 years and older, EV dominated OR as preferential treatment because effectiveness was higher than for OR and costs were lower. CONCLUSIONS: The results of this decision analysis model suggest that EV is favored over OR for patients with CMI in all age groups. Although EV is associated with more expected reinterventions, EV appears to be cost-effective for all age groups.

A clinical decision model for selecting the most appropriate therapy for uncomplicated chronic dissections of the descending aorta.

OBJECTIVE: The optimal treatment for patients with uncomplicated chronic Stanford type B aortic dissections (chTBADs) is still matter of debate. The purpose of this study was to design a decision tool to guide the surgeon in determining the preferred treatment option. METHODS: A Markov decision-analysis model compared chTBAD patients treated with initial open surgical repair (OSR), thoracic endovascular aortic repair (TEVAR), and optimal medical therapy (OMT), followed during follow-up by OSR (OMT-OSR) or TEVAR (OMT-TEVAR), if indicated. Procedural risks, aortic growth and rupture rates, outcomes, and quality of life values were derived from the best available evidence in the literature. A chTBAD treatment strategy decision tool was developed, including the four key variables of age, sex, surgical risk, and maximum initial aortic diameter. Primary outcome was quality-adjusted life-years (QALYs). RESULTS: For the reference patient cohort, 55-year-old men with chTBAD with a maximum aortic diameter of 5.0 cm, medium risk for surgery, and a threshold for surgery of 6.0 cm during follow-up, OSR yielded higher QALYs, with 10.06 QALYs (95% credibility interval [CI], 9.52-10.56 QALYs) vs 9.92 QALYs (95% CI, 9.23-10.58 QALYs) after TEVAR and 9.64 QALYs (95% CI, 9.38-9.88 QALYs) and 9.40 QALYs (95% CI, 9.11-9.69 QALYs) for OMT-OSR and OMT-TEVAR. The difference between OSR and OMT-OSR was 0.42 QALYs (95% CI, 0.01-0.81 QALYs) and between TEVAR and OMT-TEVAR was 0.52 QALYs (95% CI, 0.04-0.68 QALYs). This showed that intervention is preferred over OMT. A change of the four variables resulted in a change of preferred treatment. In general, OSR was the preferred treatment in younger patients with a larger aortic diameter and in low-risk patients. TEVAR was preferred in elderly patients with large aortic diameter and if the aortic diameter threshold for repair decreased. OMT was the optimal therapy in high-risk patients, elderly patients, or in patients with small aortic diameters. CONCLUSIONS: This decision-analysis model shows that there is no "one-size-fits-all" treatment for uncomplicated chTBADs. For the reference patient cohort, intervention is preferred over OMT. Age is the most important deciding factor, followed by initial aortic diameter. Immediate OSR is the preferred treatment option in younger patients with a large initial aortic diameter and in low-risk patients. Immediate TEVAR is preferred in elderly patients with a large initial aortic diameter and in patients with a lower threshold for OSR. OMT should be considered in high-risk patients, in patients with small initial aortic diameters, and in patients aged >80 years, unless their initial aortic diameter is >5.5 cm. However, the differences in some patient groups are clinically insignificant, allowing a major role for patient preferences and hospital-specific considerations. This clinical decision model may guide chTBAD treatment.

Metabolic syndrome is associated with type II endoleak after endovascular abdominal aortic aneurysm repair.

OBJECTIVE: Type II endoleak is usually a benign finding after endovascular abdominal aortic aneurysm repair (EVAR). In some patients, however, type II endoleak leads to aneurysm sac expansion and the need for further intervention. We examined which factors, in particular the components of metabolic syndrome (MetS), would lead to an increase risk of endoleak after EVAR. METHODS: The medical records of all patients who underwent EVAR between 2002 and 2011 at the Veterans Affairs Connecticut Healthcare System were reviewed. MetS was defined as the presence of three or more of the following: hypertension (blood pressure ≥130 mm Hg/≥90 mm Hg), serum triglycerides ≥150 mg/dL, serum high-density lipoproteins ≤50 mg/dL for women and ≤40 mg/dL for men, body mass index ≥30 kg/m(2), and fasting blood glucose ≥110 mg/dL. Development of endoleak, including specific endoleak type, was determined by review of standard radiologic surveillance. RESULTS: During a 9-year period, 79 male patients (mean age, 73.5 years), underwent EVAR for infrarenal abdominal aortic aneurysm (mean 6.2 cm maximal transverse diameter). MetS was present in 52 patients (66%). The distribution of MetS factors among all patients was hypertension in 86%, hypertriglyceridemia in 72%, decreased high-density lipoprotein in 68%, diabetes in 37%, and a body mass index of ≥30 kg/m(2) in 30%. No survival difference was found between the MetS and non-MetS groups (P = .66). There was no difference in perioperative myocardial infarction or visceral ischemia immediately postoperatively between the two groups. Patients with MetS had a significant increase in acute kidney injury (n = 7, P = .0128). Endoleaks of all types were detected in 26% (n = 20) of all patients; patients with MetS had more endoleaks than patients without MetS (35% vs 7.4%, P = .0039). Of the 19 type II endoleaks, 79% were present at the time of EVAR and only 21% developed during surveillance; 95% had MetS (P = .0007). CONCLUSIONS: Type II endoleak after EVAR for abdominal aortic aneurysm is associated with MetS. Whether these patients are subject to more subsequent intervention due to sac expansion is unclear. MetS may be a factor to consider in the treatment of type II endoleak.

Surgical and anesthetic considerations for the endovascular treatment of ruptured descending thoracic aortic aneurysms.

PURPOSE OF REVIEW: Ruptured descending thoracic aortic aneurysm (rDTAA) is a life-threatening disease. In the last decade, thoracic endovascular aortic repair (TEVAR) has evolved as a viable option and is now considered the preferred treatment for rDTAAs. New opportunities as well as new challenges are faced by both the surgeon and the anesthesiologist. This review describes the impact of current developments and new modalities for the surgical and anesthetic management of rDTAAs. RECENT FINDINGS: A collaborative approach between the anesthesiologist and surgeon during critical moments such as induction, moment of aortic occlusion and placement of the aortic stent-graft is mandatory. Important issues to consider on preoperative imaging evaluation are correct sizing of the aortic stent-graft and localization of the artery of Adamkiewicz. Emergency TEVAR should preferentially be started under local anesthesia and could be switched to general anesthesia after stent placement. Patients should be kept in permissive hypotension preoperatively and during the intervention before stent-graft deployment and relative hypertension after deployment. The use of a proactive spinal cord protection protocol could decrease the risk of spinal cord ischemia and/or paraplegia and consists of permissive hypertension after stent deployment, cerebrospinal fluid drainage to maintain adequate spinal cord perfusion, relative hypothermia and possibly use of mannitol. SUMMARY: In order to improve outcomes of TEVAR for rDTAA, a close communication between the anesthesiologist and the surgeon and a thorough understanding of the events during the procedure is mandatory. The use of a proactive spinal cord protection protocol may decrease the rates of devastating spinal cord ischemia.

Successful treatment of a proximal type I endoleak with HeliFX EndoAnchors.

We report the use of Aptus HeliFX EndoAnchors for endovascular treatment of a proximal type I endoleak after previous endovascular aneurysm repair (EVAR) of a ruptured abdominal aortic aneurysm. An 81-year-old man had been treated with EVAR after a ruptured 12 × 11 cm abdominal aortic aneurysm. Standard computed tomographic angiography follow-up demonstrated a proximal type I endoleak. Because of the highly angulated neck and close position of the endograft to the renal arteries, placement of a proximal extension cuff was prohibited; therefore, the endoleak was treated with an alternative approach using the Aptus HeliFX EndoAnchors. Nine EndoAnchors were successfully placed circumferentially on the proximal site of the endograft. This successfully treated the endoleak by excluding the aneurysm sac from the circulation. Computed tomographic angiography follow-up after 3 months showed no residual type I endoleak. This case shows that placement of EndoAnchors can serve as a viable treatment option for proximal type I endoleaks after failed EVAR.

Decision analysis model of open repair versus endovascular treatment in patients with asymptomatic popliteal artery aneurysms.

OBJECTIVE: Repair is indicated of asymptomatic popliteal artery aneurysms (aPAAs) that are >2 cm. Endovascular PAA repair with covered stents (stenting) is increasingly used. It is, however, unclear when an endovascular approach is preferred to traditional open repair with great saphenous vein bypass (GSVB). The goal of this study was to assess the treatment options for aPAAs using decision analysis. METHODS: A Markov model was developed and a hypothetic cohort of patients with aPAAs was analyzed. GSVB, stenting, and nonoperative management with optimal medical treatment (OMT) were compared. Operative mortality, patency rates, quality-of-life values, and costs were determined by comprehensive review of the best available evidence. The main outcome was quality-adjusted life-years (QALYs). Secondary outcomes were cost-effectiveness and number of reinterventions. RESULTS: For a 65-year-old male patient with a 2.0-cm aPAA and without significant comorbidities, probabilistic sensitivity analysis shows that intervention is preferred over OMT (5.77 QALYs, 95% credibility interval [CI], 5.43-6.11; OMT). GSVB treatment for this patient results in slightly higher QALYs than stent placement, with a predicted 8.43 QALYs (GSVB: 95% CI, 8.21-8.64) vs 8.07 QALYs (stenting: 95% CI, 7.84-8.29), a difference of 0.36 QALYs (95% CI, 0.14-0.58). Furthermore, costs are higher for stenting ($40,464; 95% CI, $34,814-$46,242) vs GSVB ($21,618; 95% CI, $15,932-$28,070), and more reinterventions are required after stenting (1.03 per patient) vs GSVB (0.52 per patient), making GSVB the preferred strategy for all outcomes considered. Stenting is preferred in patients who are at high risk for open repair (>6% 30-day mortality) or if the 5-year primary patency rates of stenting increase to 80%. For very old patients (>95 years) and patients with a very short life expectancy (<1.5 years), OMT yields higher QALYs. CONCLUSIONS: GSVB is the preferred treatment in 65-year-old patients with aPAAs for all outcomes considered. However, patients at high risk for open repair or without suitable vein should be considered as candidates for endovascular repair. Very elderly patients and patients with a short life expectancy are best treated with OMT. Further improvement of endovascular techniques that increase patency rates of endovascular stents could make this the preferred therapy for more patients in the future.